Indications and uses
temporarily relieves nasal congestion due to: - common cold - hay fever - upper respiratory allergies temporarily relieves sinus congestion and pressure shrinks swollen nasal membranes
12 Hour Decongestant Nasal Spray
- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Effective date
- 2021-02-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:51:28
Label at a glance#
ProductOxymethazoline HCL
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure13 sections
Dosage and administration
adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril. Not more often than every 10-12 hours. Do not exceed 2 doeses in 24 hours. children under 6 years of age: ask a doctor. Instructions for use: Shake well before use. to open, rotate cap to align the marks. Squeeze cap on toh sides in a counter-clockwise turn and pull to remove. To spray, hold bottles with thumb a...
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient
Oxymetazoline HCL 0.05%
Purpose
Nasal decongestant
Uses
temporarily relieves nasal congestion due to:
- common cold
- hay fever
- upper respiratory allergies
temporarily relieves sinus congestion and pressure
shrinks swollen nasal membranes
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
OTC - STOP USE SECTION
Stop use and ask a doctor if symptoms presist
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril. Not more often than every 10-12 hours. Do not exceed 2 doeses in 24 hours.
children under 6 years of age: ask a doctor.
Instructions for use: Shake well before use. to open, rotate cap to align the marks. Squeeze cap on toh sides in a counter-clockwise turn and pull to remove. To spray, hold bottles with thumb at base and nozzle between first and second fingers. Without tilting the head, insert nozzle into nostril. Fully depress rim with a firm even stroke and sniff deeply. Wipe nozzle clean after use and snap cap back onto bottle.
Other information
store between 20º to 25º C (68º to 77º F)
retain carton for future referance on full labeling
Inactive ingredients
benzalkoium cjloride, dibasic sodium phosphate, edetate disodium dihydrate, monobasic sodium phosphate, polyethylene glycol, propylene glycol, povidone, purified water
Questions or comments?
call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday
Warnings
Ask a doctor before use if you have
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
When using this prduct
do not use more than directed
do not use more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
temporary discomfort such as burning, stinging, sneexing, or an increased nasal discharge may occur
use of this container by more than one person may spread infection
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-5014-1 | 2024-06-19 | C162847 | 48780-1 | ba0f9c33-5a9f-a910-e053-dadaa90a0b85 | 12 Hour Decongestant Nasal Spray |
| 68071-5014-1 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-5a9f-a910-e053-dadaa90a0b85 | 12 Hour Decongestant Nasal Spray |
| 68071-5014-1 | 2021-02-19 | C162847 | 48780-1 | ba0f9c33-5a9f-a910-e053-dadaa90a0b85 | 12 Hour Decongestant Nasal Spray |
| 68071-5014-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-5a9f-a910-e053-dadaa90a0b85 | 12 Hour Decongestant Nasal Spray |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69618-050-51 | ML - Milliliter | 69618-050 | c4a41e72-f381-4770-a1cd-80c50baf9f33 | 1 | 2019-03-12 |
Products#
Every source-derived product name is available through these pages.
- Oxymethazoline HCL
- SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS
- EDETATE SODIUM
- EDETIC ACID
- PROPYLENE GLYCOL
- BENZALKONIUM CHLORIDE
- SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
- POLYETHYLENE GLYCOL, UNSPECIFIED
- WATER
- POVIDONE
- OXYMETAZOLINE HYDROCHLORIDE
- OXYMETAZOLINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68071-5014 | 68071-5014-1 |
| 69618-050 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Oxymethazoline HCL | OXYMETHAZOLINE HCL | Reliable 1 Laboratories | 7f08a97e-efe3-8ccc-e053-2a91aa0a5d79 | 2025-01-15 | Warnings | 69618-050 |
| 1b30eba1-f2ea-7445-e063-6294a90a7d67 | 8f62b52a-8dec-aef3-e053-2a95a90a61dc | 2024-06-18 | Warnings | 8f62b52a-8dec-aef3-e053-2a95a90a61dc |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.